Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Multi-purpose therapeutic saline solution FDA UDI
- Device Name
- 250 mL USP Sterile Saline, Screw Top Container FDA UDI
- Model / Reference
- 37-6270 FDA UDI
- Description
- 250 mL USP Sterile Saline, Screw Top Container FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10612479199573 FDA UDI
- 510(k) Number
- K083042 FDA UDI
- FDA Product Code
- FRO FDA UDIJOL FDA UDI
- GMDN Term
- Multi-purpose therapeutic saline solution FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-purpose therapeutic saline solution
McKesson by Mckesson Medical-Surgical Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose therapeutic saline solution.
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- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
Cleared under the same submission
K083042 also covers:
- Argyle — Cardinalhealth
- Argyle — Cardinalhealth
- Argyle — Cardinalhealth
- Argyle — Cardinalhealth
- Kendall — Cardinalhealth
- Kendall — Cardinalhealth
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI 9b2268a7-7b2a-4576-babe-0e5bb0c684fc 34 fields · synced May 30, 2026